Devices for approximating tissue and related methods of use

ABSTRACT

Devices for approximating multiple tissue edges internal to a body are disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to, and claims priority from, U.S.Provisional Patent Application Ser. No. 61/272,457 filed on Sep. 25,2009 which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

Embodiments of the present invention relate to tissue approximationclips used during surgery. In particular, embodiments of the presentinvention relate to clips that may be used to bring tissue edgesproximate to one another to close apertures created during surgery.

BACKGROUND OF THE INVENTION

During recent years, a major drive in surgery has been the developmentand application of minimally invasive approaches to traditionaloperations. In general surgery, an emphasis has been on laparoscopictechniques, which can now be applied to a majority of intra-abdominalprocedures. The resulting reduction in trauma to the abdominal wall hasa positive impact on patients undergoing abdominal operations.

More recently, there has been interest in less traumatic transluminalendoscopic surgical procedures. In transluminal endoscopic surgery, anendoscope is used to deliberately breach (puncture) the wall of thestomach or other organ to work within a body cavity such as theperitoneal cavity. Single point access surgery, is an advanced minimallyinvasive surgical procedure in which the surgeon operates almostexclusively through a single entry point, such as the patient's navel.In a transluminal endoscopic surgical procedure, a flexible endoscope(along with the required surgical tools) is inserted into the stomach,for example, through a natural anatomic opening. Once the endoscopereaches the access site in the stomach or other organ, the wall of theorgan is punctured and the endoscope advanced into the body cavity wherethe remotely controlled surgical tools can be used to perform delicatesurgical procedures. When the surgical procedure is completed, theendoscope and the tools are withdrawn through the aperture in the organwall and the aperture is closed.

Although minimally invasive surgeries have tremendous potential inreducing trauma associated with surgical procedures, several importantdevelopments should be pursued before these procedures can be widelyemployed. One such development is a safe and effective method ofapproximating two tissue edges in the body cavity so that they can bestapled or otherwise joined together. Existing tissue approximationtechniques only enable joining of two tissue edges which are already inclose proximity to one another. There is often a need to bring onetissue edge from a first location to the location of a second tissueedge in order to join them, and thereby, initiate healing.

SUMMARY OF THE INVENTION

An embodiment of the invention may include a device to approximatemultiple tissue edges. The device may include a plurality of jaws eachhaving a first end and a second end coupled at the first ends. Thedevice may also include a fixed element located between the jaws. A jawmay be independently moved with respect to the fixed element from anopen configuration to a closed configuration. The open configuration maybe a configuration where a second end of a jaw is located away from afixed element and the closed configuration may be a configuration wherea second end of a jaw mates with a fixed element to grasp a tissue edgebetween a jaw and a fixed element.

Various embodiments of the invention may include one or more of thefollowing aspects: one end of a fixed element may be coupled to a jaw atthe first end; a first end may be coupled to a distal end of an elongatemember, and a proximal end of an elongate member may be coupled to anactuation device, an actuation device may be configured to move a jawwith respect to a fixed element, and an elongate member may beconfigured to pass through a lumen of an endoscope; a fixed element mayinclude barbs; and a barb may be configured to pierce a tissue edgebetween a jaw and a fixed element.

An embodiment of the invention may also include a device to approximatemultiple tissue edges. The device may include a plurality of jaws eachincluding a first end and a second end. The jaws may be coupled to eachother at their first ends and configured to transform from an openconfiguration to a closed configuration. The open configuration may be aconfiguration where a second end of a jaw is located away from a secondend of another jaw. The closed configuration may be a configurationwhere a second end of a jaw is proximate a second end of another jaw.The device may also include one or more tools configured to pass betweenthe jaws. A tool may be configured to move relative to the jaws andgrasp a tissue edge between the jaws.

Various embodiments of the invention may also include one or more of thefollowing aspects: a first end of a jaw may be coupled to a distal endof an elongate member, and an elongate member may be configured to passthrough a lumen of an endoscope; a first end may include a hole and anelongate member may extend through the hole; a tool may be coupled to adistal end of an elongate section, a proximal end of an elongate sectionmay be coupled to an actuation device configured to be located externalto the body, and an actuation device may be configured to control a toolto grasp a tissue edge.

An embodiment of the invention may also include a device to approximatetissue edges. The device may include a plurality of jaws coupled to eachother at a first end, and a midsection located between the jaws. Themidsection may include a plurality of forks coupled together. A fork maybe configured to move to mate with a jaw and grasp a tissue edge betweenthe fork and a jaw.

Various embodiments of the invention may also include one or more of thefollowing aspects: a midsection coupled to a distal end of an elongatemember, and a proximal end of an elongate member coupled to an actuationdevice, an actuation device may be configured to move a fork; a distalend of an elongate member may include a groove, and a first end of a jawmay be located proximate a groove; and the jaws may be joined at a firstend, a first end may include a hole through which a midsection passes.

An embodiment of the invention may also include a device to approximatetissue edges. The device may include a first jaw including a proximalend and a distal end, and a second jaw including a proximal end and adistal end. A first jaw and a second jaw may be configured to transformfrom an open configuration to a closed configuration. The openconfiguration may be a configuration where distal ends of the jaws arelocated away from each other, and the closed configuration may be aconfiguration where the distal ends of the jaws are located proximate toeach other. The device may also include a barb including a first end anda second end. The first end may be coupled to a jaw. The device may alsoinclude a feature on a jaw, the feature may be configured to receive asecond end of a barb when the jaws are in the closed configuration.

Various embodiments of the invention may also include one or more of thefollowing aspects: a first jaw may move relative to a second jaw; afeature may include a hole; a jaw may include elements configured toincrease the compliance of a jaw; a barb may be configured to transformfrom a first configuration to a second configuration, the firstconfiguration may be a restricted configuration where a second end of abarb is proximate a jaw, and the second configuration may be a deployedconfiguration where a second end of a barb is distal to a first jaw; asecond end of a barb may include a sharp tip; a barb may include aplurality of spikes protruding from a surface of a barb; first andsecond jaws may be coupled to an end of an elongate member, the elongatemember may be configured to pass through a lumen of an endoscope.

An embodiment of the invention may also include a method ofapproximating tissue edges. The method may include delivering a clip toa location of a tissue edge. The clip may include a plurality of jawsand a fixed element, wherein a jaw may be moved from an openconfiguration to a closed configuration. The method may also includegrasping a tissue edge between a jaw and a fixed element, and moving aclip along with a grasped tissue edge to a location proximate to asecond tissue edge. The method may further include grasping a tissueedge between a second jaw and a fixed element, and releasing a clip witha tissue edge grasped between the jaws.

Various embodiments of the invention may also include one or more of thefollowing aspects: a fixed element may be located between the jaws; ajaw may be independently moved with respect to a fixed element; a closedconfiguration of a jaw may be a configuration where a jaw mates with afixed element, and an open configuration may be configuration where ajaw may be disposed away from a fixed element; delivering a clip mayinclude delivering a clip through a lumen of a device extending into abody; extending a clip outside a lumen may transform a jaw into an openconfiguration and retracting a clip into a lumen may transform a jawinto a closed configuration; the method may further include retracting aclip into a lumen to transform a jaw to a closed configuration; graspinga tissue edge between a jaw and a fixed element; and grasping anothertissue edge between a jaw and a fixed element; a fixed element mayinclude a barb configured to pierce a tissue edge.

An embodiment of the invention may also include another method ofapproximating tissue edges. The method may include delivering a clipincluding multiple jaws to a location of the tissue edges, anddelivering a first tool to a location of the tissue edges. The methodmay also include grasping a tissue edge using a first tool, andretracting a first tool with a grasped tissue edge to a location inbetween the jaws, and delivering a second tool to a location of thetissue edges. The method may further include grasping a second tissueedge using a second tool, and retracting the second tool with a graspedtissue edge to a location in between the jaws to approximate the tissueedges.

Various embodiments of the invention may also include one or more of thefollowing aspects: a jaw may include a proximal end and a distal end andmay be configured to transform from an open configuration to a closedconfiguration, the open configuration may be a configuration where adistal end of the jaws are located away from each other, and the closedconfiguration may be a configuration where a distal end of the jaws areproximate to each other; delivering a clip may include delivering a clipthrough a lumen of a device extending into a body; the lumen may includeone of a lumen of a catheter or a working lumen of an endoscope;extending a clip outside the lumen may transform a jaw into an openconfiguration, and retracting a clip into a lumen may transform the clipinto a closed configuration; the method may further include extending aclip outside a lumen to transform a jaw into an open configuration, andretracting a clip into a lumen to transform a clip to a closedconfiguration and grasp a tissue edge between the multiple jaws; themethod may further include releasing a tissue edge from a first tool anda tissue edge from a second tool, and releasing a clip with the clipgrasping the tissue edges; piercing the grasped tissue edges with a barbto join the tissue edges together; releasing a tissue edge from a firsttool and a second tissue edge from a second tool, and releasing a barbwith a barb piercing a tissue edge.

An embodiment of the invention may also include another method ofapproximating tissue edges. The method may include delivering a clip toa location of the tissue edges, the clip may include jaws coupledtogether, at least one jaw movable relative to another other jaw from anopen configuration to a closed configuration, and a barb coupled to ajaw. The method may also include transforming a movable jaw to a closedconfiguration to grasp a tissue edge between the jaws, and piercing thetissue edge with a barb. The method may further include moving a clipalong with a grasped tissue edge to a location proximate to anothertissue edge, and transforming a movable jaw with the grasped tissue edgeto an open configuration. The method may also include transforming amovable jaw to a closed configuration to grasp a tissue edge between thejaws, the tissue edge may be pierced by a barb.

Various embodiments of the invention may also include one or more of thefollowing aspects: a barb may pierce a tissue edge while a movable jawmay transform to a closed configuration to grasp a tissue edge; theclosed configuration may be a configuration where a distal end of eachof the jaws is proximate to each other, and the open configuration maybe a configuration where a distal end of each of the jaws is locatedaway from each other; a barb may include a first end and a second end,the first end may be coupled to a jaw and a second end may form a sharppoint; a second end of a barb may be proximate a first jaw; the methodmay further include moving a barb to a deployed orientation, wherein asecond end of a barb may be positioned to pierce a tissue edge aftertransforming the movable jaw to a closed configuration to grasp a tissueedge; the method may also include compliance features on a jaw; a barbmay include a plurality of spikes protruding from a surface of a barb;releasing a clip with a clip grasping the tissue edges; uncoupling abarb from a clip with the barb piercing the tissue edges; delivering aclip includes delivering a clip through a lumen of a device extendinginto the body, the device may include one of a catheter or an endoscope.

An embodiment of the invention may also include another method ofapproximating tissue edges. The method may include delivering a clipmounted on an elongate member to a location of a tissue edge, theelongate member may include multiple forks at a distal end, and a clipincluding multiple jaws located about the forks, wherein a fork may bemoved between a closed configuration and an open configuration. Themethod may also include moving a fork to an open configuration to graspa tissue edge between a fork and a jaw, and moving a clip along with agrasped tissue edge to a location proximate to a tissue edge. The methodmay also include moving a fork to an open configuration to grasp atissue edge between a fork and a jaw, and releasing a clip with a clipgrasping a tissue edge.

Various embodiments of the invention may also include one or more of thefollowing aspects: delivering a clip may include delivering a clipthrough a lumen of a device extending into a body; extending a clipoutside a lumen may transform a jaw into an open configuration andretracting a clip into a lumen may transform a jaw into a closedconfiguration, the open configuration may be a configuration where adistal end of the jaws is located away from each other, and the closedconfiguration may be a configuration where a distal end of the jaws islocated proximate to each other; extending a clip outside a lumen totransform a jaw into an open configuration, and retracting a clip into alumen to transform a jaw to a closed configuration and grasp the tissueedges between the jaws and the forks; retracting forks from between thejaws in the closed configuration; delivering a clip includes locating aclip on a groove of an elongate member, the groove may be locatedproximate a distal end of an elongate member; locating a second clip ona groove after releasing a clip; a fork may be independently moved withrespect to another fork between a closed configuration and an openconfiguration; and a plurality of clips may be mounted on an elongatemember.

An embodiment of the invention may also include another method ofapproximating tissue edges. The method may include delivering a clipincluding multiple jaws to location of tissue edges, wherein the jawsare configured to transform between an open configuration and a closedconfiguration, delivering a capture tool into the body, and snagging atissue edge using a capture tool. The method may also include retractinga capture tool to drag a tissue edge between the jaws, transforming thejaws to a closed configuration to grasp a tissue edges between the jaws,and releasing a clip with a clip grasping the tissue edges.

Various embodiments of the invention may also include one or more of thefollowing aspects: delivering a clip includes delivering a clip througha lumen of a device extending into a body; extending a clip outside alumen transforms the jaws into an open configuration, and retracting theclip into a lumen transforms the jaws into a closed configuration, theopen configuration may be a configuration where a distal end of the jawsis located away from each other, and the closed configuration may be aconfiguration where a distal end of the jaws are located proximate toeach other; extending a clip outside a lumen to transform the jaws intoan open configuration, and retracting a clip into a lumen to transformthe jaws to a closed configuration; delivering a capture tool into thebody may include delivering a first capture tool into the body inbetween the jaws, and delivering a second capture tool into the body inbetween the jaws; snagging tissue edges may include snagging a tissueedge using a first capture tool, and snagging a tissue edge using asecond capture tool; retracting a capture tool may include retracting acapture tool to drag a tissue edge to a location between the jaws, andretracting a capture tool to drag a second tissue edge to a locationbetween the jaws; delivering a clip includes delivering a clip mountedon an elongate member into a body, and releasing a clip includes slidinga clip off an elongate member.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description, serve to explain the principles of theinvention.

FIG. 1 is a schematic view of an endoscope performing an exemplaryendoscopic surgical procedure.

FIGS. 2A and 2B are schematic views of exemplary clips for closing anaperture created during an endoscopic surgical procedure.

FIGS. 3A-3H are illustrations of an exemplary method of using a clip.

FIG. 4 is a schematic view of another embodiment of a clip.

FIGS. 5A-5D are illustrations of an exemplary method of using a clip.

FIG. 6 is a schematic view of another embodiment of a clip.

FIGS. 7A-7E are illustrations of an exemplary method of using a clip.

FIGS. 8A and 8B are illustrations of another embodiment of a clip and amethod of using a clip.

FIGS. 9A-9D are illustrations of another embodiment of a clip and amethod of using a clip.

FIG. 10 is a schematic view of another embodiment of a clip.

FIGS. 11A-11E are illustrations of an exemplary method of using a clip.

FIGS. 12A-12E are illustrations of another embodiment of a clip and amethod of using a clip.

FIGS. 13A-13E are illustrations of another embodiment of a clip and amethod of using a clip.

FIGS. 14A-14F are illustrations of another embodiment of a clip and amethod of using a clip.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts. Even so, theinvention is not limited to the specific embodiments and drawings listedherein.

FIG. 1 depicts an exemplary endoscope 10 performing an exemplaryendoscopic surgery. Non-limiting examples of the endoscopic surgery mayinclude choecsyectomies, gastrojejunostomies, stomach resections,polypectomies, vasectomies, tubal ligations, etc. In one embodiment, anendoscope 10, or other suitable device such as a guide tube or acatheter, may be inserted into the stomach 5 through the esophagus.Endoscope 10 may make an aperture 80 on organ wall 70, pass through theaperture 80, and operate at a work site. The work site could include,for instance, part of the small intestine 50. It should be emphasizedthat the illustrated application of the endoscope 10 in FIG. 1 isexemplary only, and that the inventions of the current disclosure may beapplied to any surgical application or medical procedure known in theart.

Endoscope 10 may include an elongate member 15 extending between aproximal end 60 and a distal end 90. In the configuration depicted inFIG. 1, the proximal end 60 may include the end of endoscope 10 externalto the body and the distal end 90 may include the end of endoscope 10internal to the body. A plurality of lumens 20 may run longitudinallythrough endoscope 10. The lumens 20 may extend between the proximal end60 external to the body and the distal end 90 internal to the body. Insome embodiments, the longitudinal axes of the lumens may besubstantially parallel to the longitudinal axes of the endoscope 10.

The lumens 20 may provide access to devices and facilities that may aidin performing a diagnostic or therapeutic task inside the body. Ingeneral, the lumens may be of any shape or geometry. In someembodiments, some or all lumens may be lined with a polymeric or anotherlayer or coating to facilitate use. These lumens 20 may include one ormore of, among others, an aspiration lumen, an irrigation lumen, anillumination lumen, a viewing lumen, and working lumens. Theillumination lumen may include devices at the distal end configured toilluminate the work site. These devices may include, among others,bulbs, LED's, fiber optic cables and light guides. The viewing lumen mayinclude devices (such as a camera) at the distal end 90, configured todeliver an image of the work site external to the body. In someembodiments the camera may be a digital camera, such as a CCD or a CMOScamera. The illumination and the viewing lumens may also include cablesthat may run from the distal end 90 to the proximal end 60.

The irrigation lumen may be configured to facilitate fluid flow from theproximal end 60 to the distal end 90. In some embodiments, the proximalend 60 of the irrigation lumen may be attached to a source of fluid, andthe distal end 90 may be attached to a nozzle to alter fluid flow. Theaspiration lumen may be configured to facilitate suction and/or fluidflow through it. In some embodiments, fluid may flow from the proximalend 60 to the work site through the irrigation lumen. The fluid may thenbe removed from the work site through the aspiration lumen. In someembodiments, the aspiration lumen may also be configured to removebiological material along with fluid from the work site. For instance, atissue sample along with fluid (delivered to the work site via theirrigation lumen) may be extracted out of the body through theaspiration lumen.

The working lumen may include a hollow cavity configured to deliver anendoscopic instrument 30 to the work site. The endoscopic instrument 30may include a surgical tool configured to operate at the work site whilebeing remotely controlled from outside the body. The surgical tool maybe configured as an end effector 32 that may be attached at the distalend of the endoscopic instrument 30. In general, the working lumen mayhave any suitable shape, size, and configuration. In some embodiments,the working lumen may have a substantially circular cross-section, whilein other embodiments, the shape of the working lumen may be configuredto pass the end effector 32 of the endoscopic instrument 30 through it.Some embodiments of the endoscope may include a plurality of workinglumens to deliver multiple surgical tools to the work site.

In addition to the end effector 32, an endoscopic instrument 30 may alsoinclude a mechanism to operate the end effector 32 from outside thebody. This mechanism may include linkage that connects the end effector32 to an actuation device (not shown) at the proximal end. This linkagemay operate the end effector 32 in response to actuation by theactuation device. For example, in some embodiments, the end effector 32may include forceps with a pair of jaws rotably coupled to each other.The linkage, in this embodiment, may include a pair of cables, eachcoupled to a jaw of the forceps at the distal end and to the actuationdevice at the proximal end. Actuation of the actuation device may moveone of the cables relative to the other, causing the jaws of the forcepsto open and close.

The end effector 32 may include any medical instrument that may be usedin conjunction with the endoscope 10. In some embodiments, the endeffector 32 may be a purely mechanical medical instrument (for example,biopsy forceps, baskets, graspers, snares, surgical knifes, needles,suturing instruments, etc.), while in others, the end effector 32 mayalso include devices with parts driven by an electric current (forinstance, electric motors, heating elements for cutting or cauterizing,hemostasis devices, radio frequency ablation devices, etc.). The endeffector 32 may also include a surgical instrument, such as a trocar,used to puncture an internal surface of the body.

In the exemplary transluminal endoscopic surgery illustrated in FIG. 1,the endoscope 10 may be inserted into the body through a naturalanatomic opening (such as, mouth, anus, and vagina, etc.) or through thebody percutaneously. When the distal end 90 of the endoscope 10 isproximate to an internal surface (such as, organ wall 70), an endoscopicinstrument 30, for example, an end effector suitable for puncturingorgan wall 70, may be delivered to the distal end 90 of the endoscope 10via the working lumen. The end effector may be used to puncture theorgan wall 70. Puncturing the organ wall 70 may create cut multipletissue edges. These tissue edges may include a first tissue edge 70 aand a second tissue edge 70 b. Once the organ wall 70 is punctured, theendoscopic tool 30 with the end effector 32 may be withdrawn from theworking lumen, and the endoscope 10 inserted into the abdominal cavitythrough the aperture 80. When the distal end 90 of the endoscope 10 ispositioned at the desired work site, for instance, the intestine 50, anendoscopic instrument 30 with an end effector 32 configured to perform adesired task may be delivered to the work site through the workinglumen.

The desired operations may be performed at the work site using an endeffector 32. If more than one tool is required to complete the desiredtask, other desired end effectors 32 may also be delivered to the worksite. After completion of the desired operations, the endoscope 10 andtools may be retracted from the abdominal cavity through aperture 80.Aperture 80 may now be closed by joining the separated tissue edges (forexample, first tissue edge 70 a and second tissue edge 70 b) to initiatethe healing process. To close aperture 80, two or more tissue edgesspatially dislocated from each other may have to repositioned close toeach other (referred to herein as “approximated”) before they can bejoined together. A tissue approximation clip according to embodiments ofthe present disclosure may now be delivered to the access site 55 oraperture via the working lumen. The approximation clip may be configuredto grasp tissue edges at different locations at the access site 55,bring them in close proximity to each other, and join the tissue piecestogether.

The tissue approximation clips of the present disclosure may be made ofany suitable biocompatible material. In general, a clip may be comprisedof a material having any type of constitutive behavior, such as, amaterial exhibiting a behavior which is elastic, plastic,elastic-perfectly plastic, hyper-elastic, etc. In some embodiments, abioabsorbable material may be included. It is also contemplated, that insome embodiments, a clip may be comprised of multiple components made ofmultiple materials. In some embodiments, a clip may comprise a shapememory alloy (SMA). Non-limiting examples of SMA's included in the clipinclude alloys of titanium-palladium-nickel, nickel-titanium-copper,gold-cadmium, iron-zinc-copper-aluminum, titanium-niobium-aluminum,iron-manganese-silicon, nickel-titanium, nickel-iron-zinc-aluminum,copper-aluminum-iron, titanium-niobium, etc. In some embodiments, a clipmay comprise or consist of nitinol.

In general, clips of the present disclosure may be made by any processknown in the art. In some embodiments, arms or jaws of the clip may beformed by a bending operation of material, and holes or cavities throughthe clip may be formed by a machining or laser drilling operation. Insome embodiments, the clip may be subjected to heat treatment or othermicrostructure modification metallurgical operations during or after thefabrication process. In embodiments, where the clip may comprise a shapememory alloy, the material of the clip or the manufactured clip may besubjected to metallurgical treatments. These metallurgical operationsmay enable the clip to transform from a first configuration to secondconfiguration by the application of heat or other stimuli. The firstconfiguration may correspond to a martensitic phase and the secondconfiguration may correspond to an austenitic phase of a shape memoryalloy. Several embodiments of clips of the present disclosure and theirmethod of operation will now be described in the following paragraphs.

FIG. 2A illustrates an embodiment of the tissue approximation clip 40that may be delivered to aperture 80. Clip 40 may comprise a unitaryconstruction, and may resemble a strip of material folded along a plane54, at an angle to, and passing through a center of the strip. Clip 40may have two jaws, a second jaw 42 a and a first jaw 42 b, joined by amidsection 43. Clip 40 may further include a through-hole 46therethrough. An inside surface of the two jaws may have an irregular orcorrugated surface such as teeth 45. Although the surface corrugation ofclip 40 is depicted as teeth 45, any kind of surface configurations mayalso be used. In some embodiments, the second jaw 42 a and the first jaw42 b may be symmetric about plane 54 which may pass through a center ofthrough-hole 46. However, it is contemplated that, in some embodiments,the two jaws may not be symmetric. The through-hole 46 may have anyshape. In some embodiments, the through-hole 46 may have a circularshape.

Although clip 40 is depicted as having two jaws (second jaw 42 a andfirst jaw 42 b) and an unvarying cross-section along a thicknessdirection, it is contemplated that clip 40 may have otherconfigurations. For instance, in the embodiment of the clip 40 adepicted in FIG. 2B, clip 40 a may resemble the shape of a tulip havingat least three jaws, a second jaw 42 a, a first jaw 42 b, and a thirdjaw 42 c. The jaws may be substantially shaped like petals of the tulip.Other embodiments of the clip 40 a may have a different number of jaws.As in the embodiment illustrated in FIG. 2A, the jaws of clip 40 a maybe joined by a midsection 43 a with a through-hole 46 a centrallylocated therein. An axis 54 a may pass through a center of thethrough-hole 46 a, and an inside surface of the three jaws may have acorrugated surface or teeth 45 a.

FIGS. 3A-H illustrate an exemplary method of using a clip 40 toapproximate tissue edges and join them. One or more clips 40 may beloaded on a push-rod 22 and delivered to the access site 55 though atubular catheter 35. The clips 40 may be constrained to be in a closedconfiguration while inside the catheter 35. At access site 55, clip 40still mounted on push-rod 22 may be extended from within the catheter35. When clip 40 emerges from within the catheter 35, a constraint whichholds the clip in a closed configuration may be released, and the clipmay expand to an open configuration. It is also contemplated that insome embodiments, a constrain may force the clip to an openconfiguration when clip 40 emerges from catheter 35. The access site 55may have one or more tissue edges, a first tissue edge 70 a and a secondtissue edge 70 b, created while traversing through organ wall 70. Thefirst tissue edge 70 a may be grasped between one jaw and the push-rod22 and dragged to the location of the second tissue edge 70 b. Thesecond tissue edge 70 b may then be grasped between another jaw and thepush-rod 22. Push-rod 22 may then be pulled out from between clip 40 andretracted into catheter 35, releasing clip 40 with the tissue edgesclutched between its jaws. The released clip 40 may now approximatefirst tissue edge 70 a and second tissue edge 70 b. Each step of someembodiments of this method of operating clip 40 will now be described ingreater detail.

FIGS. 3A and 3B illustrate mounting a clip 40 on push-rod 22. Push-rod22 may be an elongate member having a groove 28 near its distal end.Past groove 28, the push-rod may include a hinge with two forks, asecond fork 24 a and a first fork 24 b. The two forks may form thedistal most part of push-rod 22. Hinge 26 may allow each fork to openindependent of the other. In some embodiments, opening of the forks maybe a purely mechanical operation, while in other embodiments, energysuch as heat and/or electricity may be used alone or in combination withmechanical energy to open the forks. While opening, second fork 24 a andfirst fork 24 b may rotate about the hinge 26. While closing, the forksmay rotate in the opposite manner. Although the forks are described asrotating about hinge 26 while opening and closing, it is alsocontemplated that in some embodiments, the two forks may move in anothermanner with respect to each other while opening and closing. Opening andclosing of the forks may be controlled by an actuation mechanism at theproximal end of push-rod 22. This actuation mechanism may includelinkages that connect the forks to the actuation mechanism. Theselinkages may open and close the forks in response to activation by theactuation device. In some embodiments, linkages may include cablescoupled to each fork. In these embodiments, pulling the cable connectedto a fork may open the fork. In other embodiments, a push rod may pushthe forks open. In some embodiments, the forks may be biased to remainin a closed configuration with a spring. In these embodiments, pullingthe cable may open the forks, and releasing the cable may close theforks.

The distal end of push-rod 22 may be inserted into through-hole 46 toload one or more clips 40 on the push-rod, such that the jaws of theloaded clips face the forks. In some embodiments, the diameter ofthrough-hole 46 and push-rod 22 may be such that frictional resistancebetween the mating surfaces of the clips and the push-rod retains clips40 on the surface of push-rod 22. The clip closest to the two forks maybe located on push-rod 22 such that through-hole 46 of the clip may bepositioned on groove 26. While clip 40 is in this position, opening afork of the push-rod may rotate the fork until it rests on teeth 45 of ajaw of clip 40. For instance, when clip 40 is located on groove 26,opening first fork 24 b may rotate this fork in a counterclockwisedirection until the first fork rests against teeth 45 of first jaw 42 b(see FIG. 3E). Further opening of the first fork 24 b may push this forkagainst first jaw 42 b.

Push-rod 22 along with the loaded clips may be inserted into a catheter35 as seen in FIG. 3C. Catheter 35 may comprise a hollow tube with anexternal diameter sized to be inserted into a working lumen of endoscope10. The jaws of clip 40 may deflect inwards from an open configurationto a closed configuration while being inserted into catheter 35. Theinternal diameter of a distal end of catheter 35 may be such that theclips in a closed configuration may slide longitudinally within thecatheter freely. Push-rod 22 may be inserted into catheter 35 such thatall the loaded clips are positioned within the catheter, and a proximalend of push-rod 22 protrudes from a proximal end of catheter 35. At somedistance near the distal end, the internal surface of catheter 35 mayhave a flange 58 designed to stop the longitudinal movement of clip 40.In some embodiments, flange 58 may be a region of reduced diameter ofcatheter 35. It is also contemplated that the flange 58 can have otherconfigurations, such as, a protrusion of a size that prevents thepassage of a loaded clip past the protrusion.

In some embodiments, the distance of flange 58 from the distal most endof catheter 35 may be factor in determining the number of clips 40 thatmay be loaded on a push-rod positioned within the catheter. The internaldimensions of catheter 35 may be configured to facilitate locating aclip on groove 28 of push-rod 22. For instance, pulling push-rod 22 in aproximal direction from the proximal end of catheter 35 may move thepush-rod, along with the loaded clips, into the catheter towards theproximal end. During this movement, a loaded clip may run into flange58. The flange may thus prevent longitudinal movement of the cliptowards the proximal end. Further pulling of the push-rod towards theproximal end may cause the push-rod to slide on the through-hole 46,thereby positioning the clip on the groove.

The catheter 35 with the inserted push-rod 22 may now be delivered tothe access site 55 through a working lumen of the endoscope 10. Theendoscope may be positioned within the body such that the distal end 90of the endoscope 10 is proximate the access site 55. FIG. 3D illustratesone embodiment of delivery of the clip 40 to an access site 55. Thecatheter 35 may be delivered such that loaded clip 40 extends from thedistal end 90 of the endoscope 10. While thus positioned, pushing thepush-rod 22 into the catheter 35 from the proximal end may extend thepush rod 22 with the loaded clip 40 out of the distal end of thecatheter 35. When the push-rod 22 is pushed into the catheter 35 toextend the clip 40 positioned on the groove 28 from the distal end ofthe catheter 35, the jaws of the clip 40 may spring back to its openconfiguration. It is contemplated that in some embodiments, the jaws maynot return completely to their pre-deformed configuration, but mayretain some plastic deformation. The distal end 90 of the endoscope 10and/or the distal end of the catheter 35 may now be maneuvered toposition extended clip 40 proximate one tissue edge (first tissue edge70 a or second tissue edge 70 b).

Clip 40 may now be used to grasp these separated tissue edges. FIG. 3Eillustrates grasping second tissue edge 70 b between the first fork 24 band the first jaw 42 b. To grasp the second tissue edge 70 b, the clip40 may be maneuvered to locate the second tissue edge 70 b between thefirst fork 24 b and the first jaw 42 b. When clip 40 is suitablypositioned, the actuation device may be used to open first fork 24 b.Opening the first fork 24 b may rotate the first fork 24 b about thehinge 26 in a counterclockwise direction. The opening first fork 24 bmay force the trapped second tissue edge 70 b against the teeth 45 ofthe first jaw 42 b thereby firmly grasping the second tissue edge 70 bbetween the first fork 24 b and the first jaw 42 b. While thus graspingthe second tissue edge 70 b, the endoscope 10 or catheter 35 may bemaneuvered to the location of the first tissue edge 70 a. When the clip40 is suitably positioned proximate the first tissue edge 70 a, thesecond jaw 42 a may be opened to grasp the first tissue edge 70 abetween the second jaw 42 a and the first fork 24 a. FIG. 3F illustratesclip 40 grasping the first tissue edge 70 a.

With the two tissue edges firmly grasped between the jaws and the forks,push-rod 22 may be pulled towards the proximal end to force clip 40towards the catheter 35. FIG. 3G illustrates one embodiment of the clip40 being pulled towards the catheter 35. While the clip 40 is beingretracted into the catheter 35, the open jaws of the clip are pushedinwards by the walls of the catheter 35. The reaction force of thecatheter 35 on the open jaws of the clip may deform the jaws with thetissue edges and the forks sandwiched between the jaws. In someembodiments, part or all of clip 40, with the tissue edges sandwichedbetween its jaws, may enter the distal end of catheter 35 as thepush-rod 22 is pulled into the catheter 35.

In some embodiments, further pulling of the push-rod 22 from theproximal end of the catheter 35 may further pull the forks out frombetween the jaws of the clip 40, leaving the tissue edges sandwichedbetween the deformed jaws of the clip. In embodiments where a part ofthe deformed clip 40 enters the distal end of catheter 35 uponretraction of the push-rod 22, retracting the catheter 35 away from theaccess site 55 may stretch the organ wall 70 to allow the clip 40 to bepulled out of the distal end of the catheter 35 with the first tissueedge 70 a and second tissue edge 70 b sandwiched between its jaws. FIG.3H illustrates a deformed clip 40 with the tissue edges grasped betweenits jaws. Clip 40 may thus close aperture 80 by joining the two tissueedges together. The action of retracting the push-rod 22 into catheter35 may also position another loaded clip 40 in the groove 28 of thepush-rod 22 as described previously.

Although the description above describes the method of closing apuncture with two tissue edges using clip 40, the same general approachcan be used to close an aperture 80 having more than two tissue edges.To close a puncture with more than two tissue edges, a clip withmultiple jaws may be used. For instance, clip 40 a with three jawsdepicted in FIG. 2B, may be used to close an aperture 80 with threetissue edges. In this embodiment, the push-rod 22 may include threeforks that may be independently opened and closed from outside the body.The clip 40 a may be loaded on the push-rod 22 and delivered to theaccess site 55 as described earlier. At the access site 55, the firsttissue edge may be grabbed between a jaw and a fork and dragged to thelocation of the second tissue edge. A second tissue edge may then begrabbed between a second jaw and a fork. The distal end of the catheter35 may then be maneuvered to the location of a third tissue edge, wherethe third tissue edge may be grabbed between the third fork and the jaw.Push rod 22 may then be retracted into the catheter to deform the jawsof clip 40 a as discussed earlier. The push-rod 22 may be furtherretracted to extract the forks from between the jaws, thereby leavingthe tissue edges pressed together by the deformed jaws. Although thedescription above describes a clip having jaws equal to the number offorks, this is not a requirement. That is, in some embodiments, thenumber of jaws of a clip may be different than the number of forks.

It is also contemplated that a device with two jaws (such as clip 40depicted in FIG. 2A) may be used to close an aperture with more than twotissue edges. In such an application, two or more tissue edges may begrabbed between a jaw and a fork. A first tissue edge may be firmlyembedded in the teeth 45 of the jaw so that it may not be released whenthe jaw is opened to grasp a second tissue edge.

FIG. 4 illustrates another embodiment of a tissue approximation clip 140that may be used to close the aperture 80. Clip 140 of FIG. 4 may beattached to a distal end of an elongate member 122, and may be deliveredto the access site 55 through the working lumen of the endoscope 10. Insome embodiments, the elongate member 122 with the clip 140 may bedelivered to the access site 55 via a catheter inserted into the workinglumen. The elongate member 122 may connect the clip 140 to an actuationdevice attached to the proximal end thereof. The elongate member 122 mayinclude mechanisms, such as links or cables, that may allow theactuation device to operate the clip 140. These actuation mechanisms maybe similar to those discussed with reference to clip 40 of FIG. 3A, ormay be different. The clip 140 may protrude from the distal end of theendoscope 10 to operate on the aperture 80.

Clip 140 may include three jaws—a first jaw 142 a, a second jaw 142 b,and a fixed center jaw 124. The jaws may have a corrugated surface,teeth 145, or other surface modifications on its facing sides. Similarto the opening left and right forks of the embodiment shown in FIGS.3A-3H, the first jaw 142 a and the second jaw 142 b may be movable andmay be opened and closed using the actuation mechanism. Closing thefirst jaw 142 a may actuate this jaw about a hinge 126 until the teeth145 on its surface presses against the teeth 145 on the fixed center jaw124. And, closing the second jaw 142 b may actuate this jaw about thehinge 126 until its teeth 145 meets the teeth 145 of the center jaw 124.The jaws may be opened by actuating the jaws in the opposite direction.In some embodiments, the first jaw 142 a and the second jaw 142 b may bebiased to remain in the closed configuration. In these embodiments, thejaws may be opened by applying an opening force to overcome the biasingforce. The jaws may actuate to a closed configuration when the openingforce is removed. In some embodiments, when a jaw is closed against thecenter jaw, teeth 145 on both jaws lock to keep the jaw in a closedconfiguration.

FIGS. 5A-D illustrate a method of using clip 140 to approximate tissueedges 70 a and 70 b and close the aperture 80. The clip 140 may beattached to the distal end of the elongate member 122 and delivered tothe site of an aperture 80 via the working lumen of the endoscope 10.FIGS. 5A and 5B illustrate the clip 140 grasping a tissue edge 70 a atthe access site 55. At the access site 55, the endoscope 10 ismaneuvered to position a first tissue edge 70 a between the center jaw124 and another jaw of the clip, for instance the first jaw 142 a. Theactuation device is then actuated to close the first jaw to firmly graspthe first tissue edge 70 a between the first jaw 142 a and the centerjaw 124. In the closed configuration, the teeth 145 of the first jaw 142a and the center jaw 124 engage, thereby locking the first jaw 142 a inthe closed configuration.

The clip 140 with the grasped first tissue edge 70 a is maneuvered tothe site of a second tissue edge 70 b. The second tissue edge 70 b ispositioned between the second jaw 142 b and the center jaw 124, and thesecond jaw 142 b closed to lock the second tissue edge 70 b between theteeth 145 of these jaws. FIG. 5C illustrates the first and second tissueedges 70 a and 70 b firmly grasped by clip 140. The clip 140 may thusclose the aperture 80 by joining together the tissue edges that form theaperture 80. Once the tissue edges are thus joined, the clip 140 may bereleased. FIG. 5D illustrates the released clip 140. The released clip140 may keep the aperture 80 closed allowing the natural healing processto grow fresh tissue around the joined tissue edges.

In general, a clip may be released from an elongate member by any means.In some embodiments a frangible link or an electrolysis link may be usedto release a clip from an elongate member. Clip 140 also may be releasedfrom the elongate member by any other suitable method, including methodsthat use the actuation mechanism. In some embodiments, a clasp mayretain the clip 140 on the distal end of the elongate member 122. Inthese embodiments, the actuation mechanism may operate the clasp torelease the clip 140. In some embodiments, the distal end of theelongate member 122 may have threads that mate with threads on a matingface of the clip 140. In these embodiments, rotating the elongate member122 about its longitudinal axis may unscrew the clip 140 from theelongate member 122, and release the clip 140.

FIG. 6 illustrates another embodiment of a tissue approximation clip 240that may be used to close the aperture 80. Clip 240 may include a firstjaw 242 a and a second jaw 242 b hinged to an elongate member 222 athinges 226 a and 226 b (see FIG. 7A), respectively. The first jaw 242 aand the second jaw 242 b may also include teeth 245 or other surfaceirregularities on facing surfaces. The clip 242 may be located at thedistal end of the elongate member 222, and may be delivered to an accesssite 55 within a catheter 35. The catheter 35 may be delivered to theaccess site 55 through a working lumen of an endoscope 10. The first jaw242 a and the second jaw 242 b may be configured to slide individuallyon elongate member 222 to extend from the distal end of the catheter 35.A hook 224 having barbs, may also be located between the first jaw 242 aand the second jaw 242 b. The barbs may be sharp needle like featuresthat protrude from the distal end of hook 224, or just a raised profileat the distal end of hook 224. Clip 240 may close aperture 80 byclamping the tissue edges between its jaws. FIGS. 7A-E illustrate amethod of using clip 240 to approximate and join tissue edges.

When the distal end of the catheter 35 is proximate the first tissueedge 70 a, the first jaw 242 a along with the hook 224 may be extendedfrom within the catheter 35. The jaws may be biased to open whenreleased from within the catheter 35. The catheter 35 and/or theendoscope 10 may be positioned to locate the first tissue edge 70 abetween the extended jaw and the hook 224. FIG. 7A shows device 240 withthe first tissue edge 70 a located between the first jaw 242 a and thehook 224. When the tissue is appropriately positioned, the first jaw 242a along with hook 224 may be retracted into catheter 35. A catch or afeature on an inside surface of the catheter 35 may prevent the secondjaw 242 b from retracting further into catheter 35 when the first jaw242 a is retracted. Withdrawing the catheter 35 may force the first jaw242 a to a closed configuration, trapping the tissue between the jaw andthe hook 224. FIG. 7B illustrates the clip 240 with the first tissueedge 70 a grasped by the first jaw 242 a and the hook 224. When thefirst jaw 242 a closes over the first tissue edge 70 a, the barbs ofhook 224 and teeth 245 of first jaw 242 a may lock, or cooperatetogether in another manner, to hold first tissue edge 70 a firmly inplace. In an embodiment of clip having sharp barbs and teeth, thesebarbs and teeth may pierce through the first tissue edge 70 a to firmlyhold the tissue edge between the jaw and the hook.

The endoscope 10 and/or catheter 35 may then be maneuvered to thelocation of the second tissue edge 70 b, and the second jaw 242 bextended from within the catheter 35 with first jaw 242 a, hook 224, andfirst tissue edge 70 a. The second jaw 242 b may spring open andposition itself over the second tissue edge 70 b, when released fromwithin the catheter 35. FIG. 7C shows clip 240 with the second tissueedge 70 b located between the second jaw 242 b and the hook 224. Oncethe jaw is appropriately positioned, the second jaw 242 b may beretracted into the catheter 35 to close the second jaw 242 b over thesecond tissue edge 70 b. FIG. 7D illustrates the clip 240 in theretracted configuration. Closing the second jaw 242 b over the secondtissue edge 70 b may also force the second tissue edge 70 b against thehook 224, forcing the barbs and the teeth into the second tissue edge 70b.

When the tissue edges are securely joined together, the clip 240 may bereleased and the catheter 35 withdrawn from the access site 55. FIG. 7Eillustrates the release of the clip 240 from the catheter 35. The clip240 along with the hook 224 may be separated from the elongate member222 by activating a detachment mechanism on the actuation mechanism. Insome embodiments, retracting the catheter 35 and/or elongate member 222may stretch the organ wall 70 exerting a force on the clip. This forcemay break the connection of the clip to the elongate member 222, therebyreleasing the clip 240 from the catheter 35. As indicated earlier, otherdetachment mechanisms may also be used to separate clip 240 fromelongate member 222. The released clip 240 may remain in the bodyclosing the aperture 80.

In some embodiments, only the hook 224, with the first tissue edge 70 aand the second tissue edge 70 b attached to its barbs, is released. Inthese embodiments, the actuation member activates a detachment mechanismreleasing the hook 224 from the elongate member 222. In theseembodiments, the hook 242 may hold the tissue edges together allowingsubsequent tissue growth to permanently join the tissue edges together.

FIG. 8A illustrates another embodiment of a clip 340 that may be used toclose aperture 80. As in clip 40, clip 340 may have two jaws, a firstjaw 342 a and a second jaw 342 b, joined by a midsection having athrough-hole 346 therein. An inside surface of the two jaws may have acorrugated surface or teeth 345. The first jaw 342 a and the second jaw342 b may be symmetric about a plane passing through a center of thethrough-hole 46. It is also contemplated that in some embodiments, clip340 may have a different structure, for instance, an annular structure.

Clip 340 may be delivered to an access site 55, mounted on the surfaceof a sheath 324. The sheath 324 may be delivered to the access site 55via a catheter 35 which slides within a working lumen of the endoscope10. In some embodiments, the catheter 35 may be eliminated, and thesheath 324 may be delivered to the access site 55 directly via theworking lumen. As described above with reference to other embodiments,clip 340 may transform from a closed configuration within the catheter35 to an open configuration outside the catheter 35. When the sheath 324is pulled into the catheter 35, the clip 340 may also retract into thecatheter 35 until the longitudinal movement of the clip is blocked byflange 58. Flange 58 may be a feature on the internal surface of thecatheter 35 that blocks a clip from sliding from the distal end of thecatheter 35 to the proximal end of the catheter 35.

The sheath 324 may have two lumens running longitudinally there-through.These lumens may include a first lumen 324 a and a second lumen 324 brunning from a distal end to a proximal end of the sheath 324. Twoendoscopic instruments with grasper end effectors, a first grasper 326a, and a second grasper 326 b, may be delivered to the access site 55through the lumens of the sheath 324. The grasper end effectors mayinclude any instrument, for example, forceps, barbed needles, etc.,configured to grasp any object within the body. In some embodiments, thefirst grasper 326 a may be delivered to the access site 55 through thefirst lumen 324 a, and the second grasper 326 b through the second lumen324 b. It is also contemplated that, in some embodiments, both graspersmay be delivered to the access site 55 through the same lumen. Thegraspers may also be extracted from the access site 55 through thelumens. Linkages 322 a and 322 b may connect the first grasper 326 a andthe second grasper 326 b, respectively, to one or more actuationmechanisms at the proximal end of the endoscope 10. These actuationmechanisms may operate the graspers at the access site 55. Operating thegraspers may include translating and rotating the graspers at the accesssite 55, and moving jaws of the grasper to grasp cut/separated tissueedges between these jaws.

At the access site 55, each grasper may be maneuvered to the location ofa piece of tissue. The first grasper 326 a may grasp the first tissueedge 70 a and the second grasper 326 b may grasp the second tissue edge70 b. The graspers, along with the tissue, may then be retracted fromthe access site 55. The sheath 324 may also be pulled into the catheter35, pulling the grasped tissue edges and the clip 340 along with it.FIG. 8B illustrates the retraction of the sheath 324 into the catheter35. During retraction, the movement of the clip 340 may be blocked bythe flange 58. Continued retraction of the sheath 324 may plasticallydeform the jaws of the clip 340 by forcing them together. The firsttissue edge 70 a and the second tissue edge 70 b may be trapped betweenthe deformed jaws, thereby joining the tissue edges together. Theactuation device may then be activated to release the tissue edges fromthe graspers 326 a, 326 b.

In some embodiments, multiple clips 340 may be mounted on the surface ofsheath 324 (as described with reference to clip 40 shown in FIGS.2A-3H). After a first clip is deployed, another clip 340 may slide downthe sheath 324 and extend out of the distal end of the catheter 35. Thissecond clip may be used to join tissue edges as described earlier.

FIGS. 9A-9D illustrate another embodiment of a clip that may be used toclose aperture 80. Clip 440 of this embodiment may be delivered to theaccess site 55 at the distal end of an elongate member 424 extendingfrom a working lumen of the endoscope. Similar to graspers 326 a, 326 bof the embodiment in FIGS. 8A-8B, a first grasper 426 a and a secondgrasper 426 b may also be delivered to the access site 55 through theelongate member 424. The graspers 426 a, 426 b may be operated at theaccess site 55 by one or more actuation mechanisms external to the body.FIG. 9A illustrates clip 440 positioned at the access site 55. Thegraspers 426 a, 426 b may extend to the access site 55 through holes orcavities in clip 440. In some embodiments, the first grasper 426 a mayextend into the access site 55 through a first through-hole 446 a andthe second grasper 426 b may extend into the access site 55 through asecond through-hole 446 b. It is also contemplated that, in someembodiments, both the first and the second graspers may extend throughthe same through-hole.

As described with reference to FIG. 8B, the first grasper 426 a maygrasp the first tissue edge 70 a and draw it into clip 440 and thesecond grasper 426 b may grasp the second tissue edge 70 b and draw itinto the clip 440. The tissue edges may be drawn into the clip byretracting the grasper into the elongate member 424. FIG. 9B illustratesa view of clip 440 with the first and second tissue pieces grasped bythe graspers. When both tissue edges are drawn into the clip 440, theactuation mechanism may be activated to release a fastener 450 to bindthe tissue edges together. Fastener 450 may include a barb or any objectconfigured to join the tissue edges. In some embodiments, the fastener450 may be released from the side of clip 440 and may penetrate thefirst and second tissue pieces to join them together. However, it isalso contemplated that fastener 450 may be released from the clip inanother manner. FIG. 9C illustrates the fastener 450 joining the twotissue edges together. After the tissue edges are securely boundtogether, the fastener 450 may be released from the clip 440. In someembodiments, the fastener 450 may be released by activating theactuation mechanism. It is also contemplated that, in some embodiments,the clip 440 may be retracted after joining the tissue edges together,and the staple may be pulled off the clip by the force of the stretchedstomach wall. FIG. 9D illustrates a view of the released fastener 450joining the two tissue edges together.

FIG. 10 illustrates an embodiment of a clip having an attached barb 550.The clip 540 attached to an elongate member 524 may be delivered to theaccess site 55 through the working lumen of the endoscope 10. As inpreviously described embodiments, the clip 540 may transform to an openconfiguration as it extends from the distal end 90 of the endoscope 10.The clip 540 may include a first jaw 542 a and a second jaw 542 bconnected at a hinge 526. The elongate member 524 may include linkagesthat connect the jaws to an actuation mechanism outside the body. Theactuation mechanism may be configured to move the jaws of clip 540towards each other and, thereby, form a closed configuration.

A barb 550 may be attached to one of the jaws, for instance, the firstjaw 542 a, of clip 540. The barb 550 may be hinged to the first jaw 542a at a first end 548 a. The second end 548 b of the barb 550 may form asharp point or an arrowhead. In some embodiments, barb 550 may alsoinclude spikes (similar to spikes 652 on barb 650 of FIG. 12A) thatprotrude from a surface of the barb 550. The barb 550 may be springloaded and the second end 548 b of the barb 550 may be retained on thefirst jaw 542 a by a catch or another mechanism. The actuation devicemay be configured to release the catch. Upon release of the catch, thebarb 550 may be configured to transform to a deployed configuration. Inthe embodiment of clip depicted in FIG. 10, the barb 550 may rotateabout the first end 548 a and snap to a second configuration (as seen inFIG. 11B). In the second configuration, the second end 548 b of the barb550 may project from the first jaw 542 a and point towards the secondjaw 542 b.

The second jaw 542 b may have a hole 528 to enable the second end 548 bof the barb to protrude through when the clip 540 is in a closedconfiguration. The second jaw 542 b may also features designed to impartsome compliance to the second jaw 542 b. In FIG. 10, these compliantfeatures are depicted as slender members arranged as a cross-hair aroundthe hole 528. These members may bend slightly when an out of plane forceis applied on the members, thereby providing compliance to the secondjaw 542 b. The purpose of the compliance will become clearer in thediscussion in reference to the operation of clip 540. In someembodiments, other forms of compliance enhancing features may beincorporated into the second jaw 542 b. It is also contemplated that, insome embodiments, the compliance enhancing features may be eliminated.

FIGS. 11A-E illustrate the use of clip 540 to approximate tissue edges(for example, first tissue edge 70 a and second tissue edge 70 b), andclose aperture 80. The endoscope 10 may be maneuvered to locate thefirst tissue edge 70 a between the open jaws of clip 540. The actuationdevice may then be actuated to grasp the first tissue edge 70 a byclosing the jaws. FIG. 11A depicts a view of clip 540 with the firsttissue edge 70 a grasped between its jaws. With the tissue firmlygrasped, the barb 550 may be released from the first jaw 542 a.Releasing the barb 550 may rotate, or otherwise actuate, the springloaded barb 550 about the first end 548 a to the second configuration.While moving to the second configuration, the sharp second end 548 b maypierce through the grasped first tissue edge 70 a. FIG. 11B depicts aview of the clip 540 with the grasped first tissue edge 70 a pierced bythe barb 550. In some embodiments, the grasped tissue may be forcedagainst the surface of the second jaw 542 b while the barb tries topierce through the tissue from the opposite side. Compliance enhancementfeatures of the second jaw 542 b may enable the barb 550 to pierce thetissue without undue trauma.

The clip 540 may again be opened using the actuation mechanism. FIG. 11Cillustrates a view of clip 540 with the jaws open. The shape of thesecond end 548 b may prevent the pierced first tissue edge 70 a frombeing released when the jaws of the clip 540 are opened. The endoscopemay again be maneuvered to position the second tissue edge 70 b betweenthe jaws of clip 540. The jaws may now be closed to grasp the secondtissue edge 70 b between the jaws. When the jaws rotate to the closedconfiguration, the pointed second end 548 b of the barb 550 may piercethe second tissue edge 70 b. FIG. 11D depicts the clip 540 with bothtissue edges pierced by the barb 550. The clip 540 may again be openedand barb 550 detached from the first jaw 542 a to release the tissueedges joined together by the barb 550. FIG. 11E illustrates the tissuepieces joined by the barb 550. In some embodiments, the barb 550 may bedetached by releasing the first end 548 a from the first jaw 542 a usingthe actuation mechanism. In embodiments of clip 540 with spikes on thebarb 550, these spikes may assist in preventing the tissue edges fromslipping off the barb 550. In some embodiments, retracting the clip awayfrom the access site 55 may stretch the organ wall 70. The stretchedorgan wall may then pull the first end 548 a off the first jaw 542 a.

In some embodiments, the entire clip 550 may be released from theelongate member 524 after the tissue edges are joined together with thebarb. Releasing the clip 540 may be accomplished by the actuation deviceor the force exerted by the stretched organ wall 70.

FIGS. 12A-12E illustrate another embodiment of a clip with a barb 650used to join cut/separated tissue edges. In the embodiment of FIG. 12A,the clip 640 may include a first jaw 642 a and a second jaw 642 battached together at a hinge 626. Clip 640 may be delivered and operatedat the access site 55 similar to clip 540 of the previous embodiment. Abarb 650 may be attached to the first jaw 642 a at a first end 648 a.The first end 648 a may be pointed and may be retained on first jaw 642a by a catch or other retention features on first jaw 642 a. The secondend 648 b of the barb 650 may project from the first jaw 642 a and pointtowards the second jaw 642 b. The second end 648 b of the barb 650 mayalso be pointed. The second jaw 642 b may also include retentionfeatures that are configured to couple to the second end 648 b andretain the barb 650 to the second jaw 642 b. The barb 650 may alsoinclude spikes 652 on its surface. The barb 650 may include spikes 652pointed to both the first end 648 a and the second end 648 b.

The second tissue edge 70 b may be positioned between the jaws of theclip 640 and the jaws closed. While closing, the barb 650 may piercethrough the second tissue edge 70 b. FIG. 12B illustrates a view of clip640 with the grasped second tissue edge 70 b. While in the closedconfiguration, the second end 648 b of the barb 650 may engage with theretention features on the second jaw 642 b. The jaws may again be openedto grasp the first tissue edge 70 a. FIG. 12C illustrates a view of theclip 640 with the jaws opened. Barb 650 may now be retained by theretention features of the second jaw 642 b. The spikes 652 on the barb650 may prevent the second tissue edge 70 b from being released when thejaws are opened. The first tissue edge 70 a may be positioned betweenthe jaws and the jaws closed again to grasp the first tissue edge 70 a.FIG. 12D illustrates the first and second tissues grasped between thejaws of clip 640. The sharp first end 648 a of barb 650 may piercethrough the first tissue edge 70 a when the jaws are closed. The barb650 may thus pierce through and join the first tissue edge 70 a andsecond tissue edge 70 b. As in the previous embodiment, the clip 640 maynow be opened and the barb 650 released from the clip 640. The barb 650may keep first tissue edge 70 a and second tissue edge 70 b joined. Insome embodiments, the entire clip 640 may be released from the elongatemember 624 to leave behind the clip 640 joining the two tissue edgestogether.

FIGS. 13A-13E illustrate another embodiment of a clip used to attachtissue edges. As in embodiments above, clip 740 may also include a firstjaw 742 a and a second jaw 742 b connected by a hinge 726. Clip 740attached to an elongate member 722 may also be delivered to the accesssite 55 through the working lumen of an endoscope 10 and may be operatedby an actuation mechanism external to the body. As in clip 40, clip 740may also include a hollow through-hole 746 at a location between thejaws.

A claw 750 attached to a flexible part 724 may be delivered to theaccess site 55 through the through-hole 746. The flexible part 724 maybe manipulated external to the body to control the claw 750 at theaccess site 55. With the jaws of the clip 740 open, the claw 750attached to the flexible part 724 may be advanced through an aperture80. FIG. 13B shows the claw 750 on an opposite side of the puncture. Theflexible part 724 and the claw 750 may now be retracted into theelongate member 722. The claw 750 may snag and drag the aperture 80along with the first tissue edge 70 a and second tissue edge 70 b intoclip 740. Claw 750 may have any shape configured to snag the tissueedges and draw them into the clip 740.

FIG. 13C illustrates a view of the clip 740 with the snagged stomachwall positioned between its jaws. Once the first tissue edge 70 a andthe second tissue edge 70 b are appropriately positioned between thejaws, clip 740 may be closed. FIG. 13D illustrates the clip 740 in aclosed configuration. The closed clip 740 may grasp the tissue edges,thereby joining them together. The clip 740 may now be released and theendoscope retracted from within the body.

FIGS. 14A-14F illustrate another embodiment of a clip 840 used to fastenfirst tissue edge 70 a and second tissue edge 70 b at access site 55.Clip 840 may be comprised of multiple arms, for instance, a first arm842 a and a second arm 842 b. Although clip 840 is depicted with twoarms, different embodiments of clip 840 may have a different number ofarms. Clip 840 may also include a center arm 850 positioned betweenfirst arm 842 a and second arm 842 b. Center arm 850 may include a barb858 positioned thereon. In some embodiments, barb 858 may be positionedat a distal end of center arm 850. Although in FIG. 14A, barb 858 isshown as a projection on center arm 850, barb 858 may have any shape andconfiguration. For instance, barb 858 may be sharp and needle shaped insome embodiments. First arm 842 a and second arm 842 b may be attachedto the center arm 850 at attachment sections 846 a and 846 brespectively, at a proximal region of the center arm 850. Any attachmentmechanism may be used to attach the first and second arms 842 a and 842b to the center arm 850. Proximal to attachment sections 846 a and 846b, center arm 850 may include protrusions 852 a and 852 b extending in aradial direction. In some embodiments, these protrusions may be springloaded. In these embodiments, the protrusions 852 a and 852 b may beconfigured to compress or depress inwards towards center arm 850 uponthe application of a radially inward force. In other embodiments,protrusions 852 a and 852 b may not be spring loaded, but may beotherwise configured to move towards the center arm 850 upon theapplication of a radially inward force. For example, protrusions 852 aand 852 b may be comprised of a compressible material.

From their respective attachment sections at the proximal region ofcenter arm 850, the first and second arms 842 a and 842 b may extend adistance longitudinally, and distally, along the length of center arm850. The first and second arms 842 a and 842 b may then be bent awayfrom the center arm 850 such that distal regions of these arms make anangle with a distal region of center arm 850. The first arm 842 a may bebent away from the center arm 850 at a first section 844 a, and thesecond arm 842 b may be bent away from center arm 850 at a secondsection 844 b. The first section 844 a may be displaced longitudinally,or offset, from second section 844 b.

A push-rod 822, coupled to a proximal end of clip 840, may be configuredto extend the clip 840 from the distal end of a catheter 835 or anendoscope to access site 55. Actuating the push-rod 822 in a distaldirection may move the push-rod 822 into the body, and may extend clip840 out of the distal end of catheter 835. Actuating the push-rod in aproximal direction may retract the distal end of the push-rod 822 alongwith clip 840 into the catheter 835.

Clip 840 may also include an end cap 860 positioned at a proximal end offirst and second arms 842 a and 842 b. The push-rod 822 may pass througha through-hole 866 on an end piece 864 positioned at a proximal end ofthe end-cap 860, to couple with the proximal end of clip 840. In someembodiments, end piece 864 may be integral with end cap 860, while inother embodiments, end piece 864 may be a part separate from end cap860. Although end cap 860 may be fitted with the end piece 864 by anymeans, in some embodiments, the end piece 864 may be interference fittedwith the proximal end of the end cap 860. Actuating push-rod 822 in aproximal direction may pull clip 840 at least partially into end cap860. As clip 840 slides into end cap 860, the walls of the end cap 860may contact the first and second arms 842 a and 842 b, and apply aradially inward force on the arms. This radially inward force maydeflect these arms towards center arm 850. Since first section 844 a andsecond section 844 b of the two arms are longitudinally displaced fromeach other, end cap 860 may contact and deflect one of these armstowards the center arm 850 at least partially before contacting anddeflecting the other arm towards the center arm 850.

FIG. 14B illustrates a configuration of clip 840 with clip 840 partiallyretracted into end cap 860. In the embodiment of clip 840 illustrated inFIG. 14 b, the end cap 860 contacts and deflects the second arm 842 btowards center arm 850 before the end cap 860 contacts the first arm 842a. When used in a procedure to fasten tissue segments 70 a and 70 b,endoscope 10 or catheter 835 with clip 840 may be maneuvered to locateone of these tissue edges, for example second tissue edge 70 b in FIG.14 b, between center arm 850 and second arm 842 b. The push-rod 822 maythen be actuated in a proximal direction to retract clip 840 partiallyinto end cap 860. As the clip 840 slides within end cap 860, internalwalls of the end cap 860 may slide on the protrusions 852 a and 852 b,and apply a radially inward force on these protrusions. This radiallyinward force may depress the protrusions 852 a and 852 b radiallyinwards towards center arm 850, thereby allowing the clip 840 to slidewithin end cap 860. Walls of end cap 860 may also contact and apply aradially inward force on second arm 842 b to deflect the second armtowards center arm 850. As the second arm 842 b deflects towards centerarm 850, second tissue edge 70 b may get held between these arms. FIG.14C illustrates an embodiment of clip 840 with second tissue edge 70 bheld between center arm 850 and second arm 842 b.

The distal end of endoscope 10 or catheter 835 may then be repositionedso that another tissue edge, for instance first tissue edge 70 a, may bepositioned between first arm 842 a and center arm 850. Further actuationof the push-rod 822 towards the proximal end may move the clip 840further into end cap 860. As the clip 840 moves further into the end cap860, walls of the end cap 860 may contact and deflect the first arm 842a towards the center arm 850 with first tissue edge 70 a between thefirst arm 842 a and center arm 850. Further actuation of the push-rod822 towards the proximal end may engage the protrusions 852 a and 852 bof center arm 850 with mating features 862 a and 862 b on end cap 860.In some embodiments, mating features 862 a and 862 b may be cavities inend cap 860 that are dimensioned to fit the protrusions 852 a and 852 btherein. Alignment of the protrusions with the mating features mayrelieve any constraining force from the protrusions, and allow theprotrusions to spring back, or recover, to their original pre-depressedconfiguration. Engagement of the protrusions 852 a and 852 b with themating features on end cap may lock the first and second arms 842 a and842 b in a closed configuration, where these arms press against centerarm 850 with the first and second tissue pieces 70 a and 70 b firmlygrasped between them. In embodiments where center arm 850 includes abarb 858, the barb 858 may also assist in firmly securing the tissueedges between the arms. FIG. 14D illustrates an embodiment of clip 840with the arms locked in a closed configuration.

Engagement of the protrusions 852 a and 852 b with the mating features862 a and 862 b on end cap 860 may also prevent the clip 840 fromsliding further into the end cap 860 upon further actuation of thepush-rod 822 towards the proximal end. Further actuation of push-rod 822may stretch organ wall 70 and exert a force on the proximal end of clip840. This force may detach the distal end of push-rod 822 from theproximal end of clip 840. As in other embodiments, any clip releasemechanism (such as, threaded connections, frangible link, electrolysislink, etc.) may be used to separate push-rod 822 from the clip 840. FIG.14E illustrates an embodiment of clip 840 with the push-rod 822 detachedfrom clip 840.

After the push-rod 822 detaches from clip 840, further retraction of thepush-rod 822 towards the proximal end may cause a protrusion 824 on thepush-rod 822 to abut against end piece 864. In some embodiments, thepush-rod 822 and end cap 860 may be dimensioned such that protrusion 824of the push-rod abuts against end piece 864 when the push-rod 822detaches from clip 840. Although protrusion 824 is depicted as a bend inpush-rod 822, the protrusion 824 may be of any form. Further actuationof the push-rod 822 may force the protrusion 824 against end piece 864and cause the end piece 864 to be dislodged from the proximal end of theend cap 860. FIG. 14F illustrates an embodiment of clip 840 with the endpiece 864 separated from end cap 860. The push-rod 822 may now beretracted out of the body through the catheter or endoscope.

Other methods may also be used to disengage the push-rod 822 from theend cap 860. In some embodiments, through-hole 866 may be configured toallow the push-rod 822 to be rotated and extracted from the end cap 860.For example, the through-hole 866 may have two different cross-sectionalshapes along two directions. In these embodiments, a cross-section ofthe through-hole along one direction may correspond to a diameter of thepush-rod 822, and the cross-section of the through-hole along anotherdirection may correspond to the thickest region of the protrusion 824.Rotating the push-rod 822 to align protrusion 824 with the directionhaving a matching cross-section of the through-hole will allow thepush-rod to be removed from end cap 860. In some embodiments, theprotrusion 824 may be a c-shaped bend on push-rod 822 and thethrough-hole 866 cross-sectional shapes along two different directionsmay correspond to a diameter of the push-rod 822 and a dimension of thec-shaped bend on push-rod 822. In such an embodiment, rotation of thepush-rod 822 may extract the push-rod 822 through the through-hole 866.In some embodiments, rotation of the push-rod 822 may retract thepush-rod 822 partly through the through-hole 866 and engage the endpiece 864 with the push-rod 822. In these embodiments, further actuationof the push-rod 822 may detach the end piece 864 from the end cap 860,leaving clip 840 in a locked configuration grasping the first and secondtissue edges 70 a and 70 b.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the disclosed systems andprocesses without departing from the scope of the invention. Forinstance, an adhesive, tissue growth promoter, or another agent may beused in conjunction with any clip to promote the fastening of the tissueedges or the healing process. Also, any part of the clip may bebioabsorbable or conduct heat and/or electricity to aid in tissuefastening or the healing process. Although the disclosure discussesseveral embodiments of a clip used in an endoscopic procedure, ingeneral, clips of the current disclosure may be used to approximatetissue edges in any medical procedure, such as in conventional surgeryor other types of medical procedures. Other embodiments of the inventionwill be apparent to those skilled in the art from consideration of thespecification and practice of the invention disclosed herein. It isintended that the specification and examples be considered as exemplaryonly, with a true scope of the invention being indicated by thefollowing claims.

1. A device to approximate multiple tissue edges, comprising: aplurality of jaws each having a first end and a second end, theplurality of jaws being coupled at the first ends; and a fixed elementlocated between the jaws, wherein each jaw may be independently movedwith respect to the fixed element from an open configuration to a closedconfiguration, the open configuration being a configuration where thesecond end of the jaw is located away from the fixed element and theclosed configuration being a configuration where the second end of thejaw mates with the fixed element to grasp one or more tissue edgesbetween a jaw and a fixed element.
 2. The device of claim 1, wherein oneend of the fixed element is coupled to the plurality of jaws at thefirst end.
 3. The device of claim 1, wherein the first end is coupled toa distal end of an elongate member, and a proximal end of the elongatemember being coupled to an actuation device, the actuation device beingconfigured to move each jaw of the plurality of jaws with respect to thefixed element, and the elongate member being configured to pass througha lumen of an endoscope.
 4. The device of claim 1, wherein the fixedelement includes barbs, the barbs being configured to pierce the one ormore tissue edges between the jaw and the fixed element.
 5. A device toapproximate multiple tissue edges, comprising: a plurality of jaws eachincluding a first end and a second end, the jaws being coupled to eachother at their first ends and configured to transform from an openconfiguration to a closed configuration, the open configuration being aconfiguration where the second ends of the jaws are located away fromeach other, and the closed configuration being a configuration where thesecond ends of the jaws are proximate to each other; and one or moretools configured to pass between the jaws, the one or more tools beingconfigured to move relative to the jaws and grasp one or more tissueedges to position the tissue edges between the jaws.
 6. The device ofclaim 5, wherein the first ends of the jaws are coupled to a distal endof an elongate member, and the elongate member being configured to passthrough a lumen of an endoscope.
 7. The device of claim 6, wherein thefirst ends include a hole and the elongate member extends through thehole.
 8. The device of claim 5, wherein each tool of the one or moretools is coupled to a distal end of an elongate section, a proximal endof the elongate section being coupled to an actuation device configuredto be located external to the body, the actuation device beingconfigured to control the tool to grasp the tissue edges.
 9. A device toapproximate tissue edges, comprising: a plurality of jaws coupled toeach other at a first end; and a midsection located between theplurality of jaws, the midsection including a plurality of forks coupledtogether, wherein each fork is configured to move to mate with a jaw andgrasp one or more tissue edges between the fork and a jaw.
 10. Thedevice of claim 9, wherein the midsection is coupled to a distal end ofan elongate member, and a proximal end of the elongate member beingcoupled to an actuation device, the actuation device being configured tomove each fork.
 11. The device of claim 10, wherein the distal end ofthe elongate member includes a groove, and the first end of theplurality of jaws is located proximate the groove.
 12. The device ofclaim 9, wherein the plurality of jaws are joined at a first end, thefirst end including a hole through which the midsection passes.
 13. Adevice to approximate multiple tissue edges, comprising: a first jawincluding a proximal end and a distal end; a second jaw including aproximal end and a distal end, the first jaw and the second jaw beingconfigured to transform from an open configuration to a closedconfiguration, the open configuration being a configuration where thedistal ends of the jaws are located away from each other, and the closedconfiguration being a configuration where the distal ends of the jawsare located proximate to each other; a barb including a first end and asecond end, the first end being coupled to the first jaw; and a featureon the second jaw, the feature being configured to receive the secondend of the barb when the two jaws are in the closed configuration. 14.The device of claim 13, wherein the first jaw moves relative to thesecond jaw.
 15. The device of claim 13, wherein the feature includes ahole.
 16. The device of claim 13, wherein the second jaw includeselements configured to increase the compliance of the second jaw. 17.The device of claim 13, wherein the barb is configured to transform froma first configuration to a second configuration, the first configurationbeing a restricted configuration where the second end of the barb isproximate the first jaw, and the second configuration being a deployedconfiguration where the second end of the barb is distal to the firstjaw.
 18. The device of claim 13, wherein the second end of the barbincludes a sharp tip.
 19. The device of claim 13, wherein the barbincludes a plurality of spikes protruding from a surface of the barb.20. The device of claim 13, wherein the first and second jaws arecoupled to an end of an elongate member, the elongate member beingconfigured to pass through a lumen of an endoscope.